DrugPatentWatch Database Preview
QSYMIA Drug Profile
When do Qsymia patents expire, and when can generic versions of Qsymia launch?
Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-four patent family members in nineteen countries.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
Summary for QSYMIA
| International Patents: | 64 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 9 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for QSYMIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QSYMIA |
| DailyMed Link: | QSYMIA at DailyMed |
Generic Entry Opportunity Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for QSYMIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Woman's | Phase 3 |
| AstraZeneca | Phase 3 |
| University of Cincinnati | Phase 2 |
Recent Litigation for QSYMIA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| VIVUS, INC. v. TEVA PHARMACEUTICALS USA, INC. | 2015-04-15 |
| VIVUS, INC. v. ACTAVIS LABORATORIES FL, INC. | 2014-06-12 |
Pharmacology for QSYMIA
| Drug Class | Sympathomimetic Amine Anorectic |
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for QSYMIA
| 960078-81-3 |
| Phentermine / topiramate |
| Phentermine and topiramate |
| Phentermine mixture with topiramate |
| Phentermine Topiramate |
| PWDLDBWXTVILPC-WGAVTJJLSA-N |
| Qnexa |
| Qsiva |
| Topiramate / Phentermine |
| VI 0521 |
| VI-0521 |
US Patents and Regulatory Information for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for QSYMIA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg | ➤ Subscribe | Start Trial |
International Patents for QSYMIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2010013503 | Start Trial |
| Canada | 2727319 | Start Trial |
| Denmark | 1187603 | Start Trial |
| Canada | 2686633 | Start Trial |
| Hong Kong | 1213489 | Start Trial |
| Mexico | 2010013505 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
